This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells

The number and severity of toxicity incidents will indicate the level of tolerance for MV-NIS in the therapy of MPM. Non-hematologic toxicities will be evaluated via the CTCAE v4.0 standard toxicity grading. Hematologic toxicity measures such as anemia, neutropenia and thrombocytopenia will be assessed using continuous variables as the outcome measures (nadir and percent change from baseline values) as well as categorization via CTCAE v4.0 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

Secondary Outcome Measures:

Describe the safety of the intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma for all cycles out to 90 days. [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]

The number and severity of adverse events (AE) over the course of up to 6 cycles of MV-NIS therapy will indicate the level of tolerance for MV-NIS in the therapy of MPM. AE will be evaluated similar to the primary outcome via the CTCAE v4.0 standard toxicity grading and frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

Patients receive the oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intrapleurally. In the absence of unacceptable side effects or disease progression treatment can be repeated every 28 days for up to 6 courses.

After completion of study treatment, patients are followed up every 3 to 6 months for up to 5 years.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

PRE-REGISTRATION:

Diagnosis of MPM, confined to single pleural cavity, with histologic confirmation of the primary tumor

CT imaging review submission to confirm unilateral pleural involvement; this review for CT imaging is mandatory prior to registration to confirm eligibility; it should be initiated as soon as possible after pre-registration

Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

Exclusion Criteria:

PRE-REGISTRATION

Uncontrolled intercurrent illness including, but not limited to:

Active infection =< 5 days prior to pre-registration

Psychiatric illness/social situations that would limit compliance with study requirements

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

Pregnant women

Nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception

Any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) or any other treatment specifically for treating the current malignancy

Immunocompromised patients, including patients known to be HIV positive

Other active malignancy =< 2 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix

History of organ transplantation

Known hepatitis B or C

Treatment with oral/systemic corticosteroids; NOTE: with the exception of topical or inhaled steroids

Exposure to household contacts =<15 months old or household contact with a person with known immunodeficiency

Allergy to measles vaccine or history of severe reaction to prior measles vaccination

Allergy to iodine; NOTE: this does not include reactions to intravenous contrast materials

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503177